Key Foundational Layers• Classification, Vocab,

Web Stds

–Classification • Content Model

(Taxonomy)

– Web Std Tech Requirements

• W3C, cloud, online, offline• Digital Signing - PKI x.509• Business Process model

support• Export / Import format

» (XML, RDF/XML)

Core Tech Architecture Discussion

• Content Model = eTMF Domain Classification

– Conceptual model– Supports vocabulary,

relationships– Includes core metadata,

domain metadata– W3C RDF/XML

• Data Model = eTMF Instance for a Study

– Instance of digital content for a single study

– Includes content model in use– Pointers to content resources– W3C XML

Content Model and Data Model

Content Model

Data Model

Metadata

StudyDigital Content

eTMF Domain Classification

eTMF Instance for Study

• Ontology’s are used to define conceptual models for a domain– Related Domains using ontology and W3C RDF/XML to define their

domain model:

• CDISC/FDA PhUSE project – Interoperable data standards initiative

• NCI Thesaurus – Published semantic concepts, vocabulary in National

Center for BioMedical Ontology (NCBO)

• HL7 Model Interchange Format — RIM, data types, and HL7 vocabulary

• Propose use of ontology and W3C RDF/XML to represent eTMF domain• eTMF Content Model can be edited, validated with free open source

editor, Protégé• eTMF Data Model can be edited, validated with XML editors

Proposed use of Ontology for eTMF Domain

• Data model is used to define an instance of the content model• Data model defines a single clinical trial study / archive• Contains content model in use, metadata in use, links to content

resources • Can be used online / offline• Supports viewing of data model in web browser• Universally exchangeable, interoperable• W3C XML format proposed (V1.0 encoding = UTF-8)

Proposed eTMF Data Model

• Use of Semantic technologies for representation of interoperable content models in Health Sciences:– HL7 Semantic Tech:

http://www.genomeweb.com/informatics/qa-io-informatics-charles-mead-efforts-adopt-semantic-web-translational-medicine

– CDISC / FDA PhUSE: http://www.prweb.com/releases/PhUSECDISC/SemanticTechnology/prweb11065477.htm

– NCI Thesaurus:

http://purl.bioontology.org/ontology/NCIT

-- CareLex – eTMF Content Model: http://purl.bioontology.org/ontology/CareLex/

• Proposed OASIS eTMF Standard Architecture:– http://carelex.org/downloads/ CareLex Content Model Spec – V1.03

• Architecture is outlined in Section 2, Pg 4.

Resources - Content Model, Arch